Medical Device Link The Online Information Source for the Medical Device Industry.

FDA is so understaffed that it would, at its present pace, take 27 years to inspect each foreign plant manufacturing medical devices for the U.S. market, according to a Government Accountability Office report. This adds fuel to the criticism that FDA is a “fundamentally broken” agency that can no longer be counted on to protect the public health, reports the New York Times. The number of foreign plants making medical devices for the U.S. market has soared in recent years, especially in China. But FDA has not had the resources to keep up.

It is time for Congress and the Bush Administration to stop fidding around and give the agency what it needs to accomplish its mission.

– From MD&DI’s blog.

CDRH wants feedback from industry on the guidance documents it might develop in 2008. The center recently released a list of general topics and more-specific subtopics that may be developed into guidance documents in 2008.

In seeking MDUFMA reauthorization, FDA agreed to meet several goals in return for additional funding from industry. One such goal was for CDRH to annually post a list of guidance document topics under consideration. Another was to provide stakeholders with a chance to comment on or construct draft language for these topics, as well as to provide suggestions for new or different guidances. Officials hope that the docket can become an important tool in making information available to the public as well as receiving input from interested parties.

The list includes topics in various stages of review at the FDA level; some topics could simply benefit from updated guidances, some have been presented in Level 1 drafts that may be finalized after public comments are reviewed, and others have no guidance associated with them.

CDRH concedes that it will not be able to complete the entire annual agenda for numerous reasons. Input from industry, therefore, will help prioritize the development of documents as well as the allocation of resources.

The general topics are listed in the sidebar on this page. The center invites all interested parties to submit comments on the proposed guidance documents on the list to Docket 2007N-0357, which FDA established for comments on all proposed FY 2008 guidance documents. Comments can include draft language on the topics or suggestions for different guidance documents.

Interested persons may submit written or electronic comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Ln., Rm. 1061, Rockville, MD 20852.

For more information, including a complete list of the proposed topics, visit www.fda.gov/cdrh/mdufma/guidance/agenda/fy08.html.

– Lawrence Lloyd

FDA and Duke University Medical Center (Durham, NC) have begun a collaboration whose results could change how clinical trials for medical devices and drugs are conducted.The collaboration will establish a public-private partnership with representatives from industry, academia, government, professional societies, and patient advocacy groups. This group will be charged with coming up with new standards for trials. It will also be asked to recommend methods and technologies that make trials safer, elicit better information from them, and produce a more efficient research process.

The collaboration is an outgrowth of FDA’s Critical Path program, which seeks to make clinical research a less cumbersome process, so that medical devices and other regulated products can ultimately get to market more quickly. Robert Califf, MD, Duke’s vice chancellor for clinical research, will chair the partnership. The cochair will be Rachel Behrman, MD, director of FDA’s Office of Critical Path Programs.

The initiative will explore several ideas, including:

• Setting up national standards for a variety of research functions. This could include developing standardized electronic forms for data collection. This is needed because the current processes for starting and conducting clinical trials are too slow and complex.
• Changing the institutional review board model. In the current setup, companies are ill-equipped to avoid duplication effort at multisite trials.
• Introducing accreditation programs for clinical investigators and research sites. Right now it is cumbersome to verify the credentials of clinical researchers and research sites. A new system could work somewhat like a hospital accreditation program.
• Adopting electronic data management systems. This would enable researchers to track data in real time and spot trends more quickly. Also, if these systems were standardized, that would make it easier to compare data from different trials.

The initiative will start by trying to solve simple issues for which there is consensus, before moving on to tougher topics. It will take several years to complete.

– Erik Swain

By summer 2008, the U.S. Supreme Court will likely have made a decision that affects device manufacturers and their protection from certain product liability lawsuits brought about by states. The ruling in the case of Riegel v. Medtronic concerns devices that are on the market via the premarket approval (PMA) process.The Court’s decision could also affect how companies develop products and how they assess risk. The case was argued on December 4.

In 2006, the Second U.S. Circuit Court of Appeals upheld a lower court ruling that dismissed Riegel v. Medtronic. It stated that the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act give FDA ultimate say over the safety and effectiveness of PMA products. Thus, those issues are not for state courts to decide. As a result, Medtronic wasn’t liable for injury that occurred when the company’s catheter burst inside the patient, Charles Riegel, during surgery.

The plaintiff appealed the ruling, and the Supreme Court agreed to hear the case, despite protests from the Bush administration. “Medtronic had won in the Second Circuit, the government had filed an amicus brief saying don’t take the case, and the Court took the case anyway,” says James Beck, attorney at Dechert LLP (Philadelphia). “To me, that’s not a particularly auspicious sign. It doesn’t mean the case [against Medtronic] is in great danger, but it would’ve been preferable, from the defense’s point of view, [if they had] never taken the case.”

Device advocates, clearly not happy with the Court’s move to hear the case, filed a joint amicus brief to urge the importance of FDA’s position as the sole authority on the safety and effectiveness of medical devices. The brief was filed by AdvaMed, the Medical Device Manufacturers Association, Medmarc Insurance Group, and DRI, an international attorney organization, in October.

The brief asserts that a state-law liability approach to evaluating devices would be detrimental to innovation and would hinder patient access to technology. It also argues that decreased innovation, as a result of such liability risk, would hurt the economy.

“The safety and efficacy of medical technologies are best determined by FDA scientists—not by lawsuits filed in courtrooms,” says Christopher White, executive vice president and general counsel at AdvaMed. White adds that state court liability cases would undermine FDA’s scientific method of approving devices and could lead to conflicting standards.

Former FDA chief counsel Daniel Troy is counsel for those named on the amicus brief. “What we tried to do was not just argue the legal issue, but talk about the broader public health implications. [This] liability environment diminishes access, increases price, reduces innovation, and creates negative incentives for proper risk communication,” he says.

“What happens in these suits is that FDA is basically second-guessed by a completely nonscientific state jury. Many members of the jury may have no scientific training at all, and they tend to make a decision not based on what the company or product did, but on what happened to the plaintiff,” says Troy. “The worse the [patient] outcome, the more likely it is that the jury makes an award sympathetic to that person.”

A state-law liability approach likely won’t change the way FDA assesses devices. However, Beck thinks it might result in disproportionate caution and less innovation among manufacturers. It might also cause them to submit excessive material to FDA.

Troy adds that if companies could be sued under state law, regardless of their involvement with FDA, it might drive them to overwarn on product labeling. “We’ll end up with these incredibly prolix labels that nobody can understand.”

If Medtronic loses, Beck thinks it would also influence how companies develop products. He says it wouldn’t change FDA’s evaluations, but it could cause companies to rethink whether it is worthwhile to push ahead with certain cutting-edge devices that might also carry significant risk. “Even though this case involves Medtronic, it would probably be more severe for smaller companies than it would be [for] Medtronic, which is able to take a product liability hit every now and then.”

There’s no doubt that if the Court holds there’s no preemption, plaintiffs will introduce more lawsuits against companies that market PMA devices. Beck believes a ruling against Medtronic would result in “exponential increase” in product liability exposure.

“We’re hopeful that the Supreme Court will agree with the vast majority of circuits that have found that a PMA preempts state court suits that are inconsistent with FDA’s determination that the product is safe and effective,” says Troy. “[The decision is] certainly going to be definitive on the question of preemption for PMA devices. It won’t be definitive on the question of liability, because you always have to litigate liability, causation, and fault in these cases.”

– Maria Fontanazza

He isn’t getting much credit yet for accomplishments at FDA, but Commissioner Andrew von Eschenbach deserves at least some recognition for propelling the cause of greater transparency where agency conflicts of interest are concerned. He may not, however, realize just how much there is to this topic.At the end of October, FDA published a draft guidance on the disclosure of financial interests by members of all FDA advisory committees. A few weeks later, the agency published another on the proper way such members should vote on products under review. These are small but positive steps on the road to more transparency and, by inference at least, accountability.

FDA advisory committee members are officially special government employees and, as such, have to make public disclosures about the regulated companies with which they have been financially involved. Permanent government employees are, of course, prohibited from having these sorts of financial relationships with the companies they regulate. But FDA employees are not required to disclose conflicts of interest before acting for or against a regulated company. Von Eschenbach will discover a very tangled web in this area, if he looks.

Minority House Energy and Commerce Committee members Joe Barton (R–TX) and Ed Whitfield (R–KY) asked von Eschenbach to do just that in November, addressing a decade of unsupervised and allegedly abusive CDRH enforcement actions against small device companies.

In a three-page letter citing an ongoing CDRH civil monetary penalties case, Barton and Whitfield asked the commissioner to “personally review how center directors monitor top disputes and controversies, and report back on management performance in this area, and whether any further steps or actions will be taken to improve dispute resolution and priority setting of enforcement resources.” They asked for a report from the commissioner by December 14, 2007. Although the letter did not mention TMJ Implants by name, the details described in the letter matched its case.

Dispute resolution is an area in which FDA has been fraught with internal and undisclosed conflicts of interest of the ethical and interpersonal kind. Barton and Whitfield wrote that they “question whether the greatest public health impact is being achieved by FDA pursuing a protracted dispute with a small company rather than using good-faith dispute resolution. The case involves a four-year-old dispute over a medical device firm not submitting 17 reports, for which FDA is seeking $10,000 per violation and $510,000 in total civil money penalties.”

The congressmen reminded von Es­chenbach that they had written him in April on this issue and noted that FDA responded in late July. In that response, FDA deflected questions about whether FDA’s commissioner has decided any appeal in the past 10 years, such as the appeal TMJI filed, in favor of the appellant and whether it has “mooted out” an appeal, as it did in TMJI’s case, because of an intervening enforcement action.

That’s where FDA appears to have had an undisclosed conflict of interest. The staff attorney who advised the commissioner’s office to turn back TMJI’s appeal unconsidered, Vernessa Pollard, was reportedly then working on the development of a civil monetary penalties complaint against the Golden, CO–based company. That complaint was filed a few days later, after which action government rules would have prevented her from advising on the appeal.

Legally, it’s not a conflict—but ethically? Pollard declined to answer a question on this that I e-mailed to her.

Small device companies whose ordeals are now legend have long histories at FDA of similar hidden, not-strictly-illegal conflicts of interest among agency personnel. “Stacked” advisory committees to achieve FDA staffers’ desired results on a product are not unknown, for example.

Von Eschenbach’s recent predecessors have tolerated these conflicts because the companies have lacked the resources and political connections to incite public outrage.

Now Barton and Whitfield are on a warpath over the same issue, giving their party’s appointee at FDA, von Eschenbach, yet another chance to show his reformist mettle.

– James G. Dickinson

Once again, anger at the pharmaceutical industry is throwing a wrench into something that could help the device industry.

Some in Washington are casting doubts about the credibility of the Reagan-Udall Foundation before it has even had a board meeting. The foundation’s goal is to do research on how to help FDA increase product safety, encourage innovation, and modernize product development. But an influential Congresswoman and several advocacy groups are expressing concern that the foundation could be a tool for the pharmaceutical industry to inappropriately influence FDA policy, the Star-Ledger of Newark, NJ reports.

Former FDA Commissioner and CMS Administrator Mark McClellan, who heads the foundation, said it will support FDA by “focusing on science and doing the right thing for patients.” All decisions regarding research projects will be made public, as will disclosures about where the foundation’s funding comes from, he said. FDA has the last word on whether any of the foundation’s proposals are implemented, and Congress will have oversight responsibility. The foundation was created as part of last year’s FDA Amendments Act.

But last month, Congresswoman Rosa DeLauro (D-CT), head of the subcommittee that determines FDA’s appropriation, added a provision to a spending bill that prevents FDA from contributing any money to the Reagan-Udall foundation in 2008. And one board member, a former GlaxoSmithKline executive, has come under fire for allegedly intimidating a professor who had negative findings about GSK’s controversial diabetes drug, Avandia. Also, several advocacy groups, including the Consumers Union and the Union of Concerned Scientists, have gone on record with skepticism about whether the foundation will be a tool of industry.

All of this is an overreaction that will hinder the foundation’s ability figure out better ways to get safer and more effective medical devices on the market more quickly. But because of the pharmaceutical industry’s intensive lobbying efforts, excessive campaign contributions, and safety-related scandals in recent years, anything it touches is going to come under suspicion. And this is too bad for the device industry, as well as all other FDA stakeholders.

– Erik Swain